More information, please [Study Assessment]
Hello: It is a very well known drug and many MR formulations are on the market. (You have experience with this drug). All except one formulation show dose proportionality from lowest to highest strength. The one which does not is almost dose proportional. We used that in our clinical protocol to justify our study design of using just two doses. We do have intermediate doses between the low and the high.
There are only two does levels to plot. The relationship is as follows:
LnPK=B0+B1*Ln(dose) where LnPK pertains to Cmax or AUC.
So we have a regression line going through the points: we evaluate the slope (B1), intercept and the confidence intervals about the slope to evaluate dose proportionality. Brian Smith in Pharm Research year 2000 has extended the approach from the original UK working party. It seems that you can calculate intrasubject and intersubject variance e.g. for AUC and partial AUC from this approach. I do not follow how to do it. I use the usual intrasubject and intersubject values from Phoenix WinNonlin 6.4 and I am happy with that.
Angus
There are only two does levels to plot. The relationship is as follows:
LnPK=B0+B1*Ln(dose) where LnPK pertains to Cmax or AUC.
So we have a regression line going through the points: we evaluate the slope (B1), intercept and the confidence intervals about the slope to evaluate dose proportionality. Brian Smith in Pharm Research year 2000 has extended the approach from the original UK working party. It seems that you can calculate intrasubject and intersubject variance e.g. for AUC and partial AUC from this approach. I do not follow how to do it. I use the usual intrasubject and intersubject values from Phoenix WinNonlin 6.4 and I am happy with that.
Angus
Complete thread:
- Dose Proportionality and Variance AngusMcLean 2016-05-11 16:55 [Study Assessment]
- More information, please Helmut 2016-05-12 14:34
- More information, pleaseAngusMcLean 2016-05-13 16:40
- Setup in Phoenix/WinNonlin Helmut 2016-05-14 02:26
- Setup in Phoenix/WinNonlin AngusMcLean 2016-05-14 18:54
- Setup in Phoenix/WinNonlin Helmut 2016-05-15 14:47
- Setup in Phoenix/WinNonlin AngusMcLean 2016-05-15 15:17
- Phoenix 64 Warning Helmut 2016-05-15 15:56
- Phoenix 64 Warning AngusMcLean 2016-05-15 20:11
- OT: imperial vs. metric units Helmut 2016-05-16 16:26
- Phoenix 64 Warning AngusMcLean 2016-05-15 20:11
- Setup in Phoenix/WinNonlin ElMaestro 2016-05-15 20:54
- Setup in Phoenix/WinNonlin AngusMcLean 2016-05-15 22:30
- Phoenix 64 Warning Helmut 2016-05-15 15:56
- Setup in Phoenix/WinNonlin AngusMcLean 2016-05-15 15:17
- Setup in Phoenix/WinNonlin Helmut 2016-05-15 14:47
- Setup in Phoenix/WinNonlin AngusMcLean 2016-05-16 21:00
- NCSS vs. PHX/WNL vs. SAS Helmut 2016-05-17 01:50
- NCSS vs. PHX/WNL vs. SAS - Validation? mittyri 2016-05-18 08:23
- Diagnostics ElMaestro 2016-05-18 09:20
- Diagnostics: R and Phoenix Helmut 2016-05-18 15:14
- Diagnostics: R zizou 2016-05-22 19:07
- Diagnostics: R Helmut 2016-05-23 01:22
- SASian potpourri d_labes 2016-05-24 12:02
- Compilation Helmut 2016-05-24 14:27
- REML or not d_labes 2016-05-24 16:33
- complete or not Helmut 2016-05-24 16:57
- Compilation AngusMcLean 2016-05-26 16:46
- doubts about NCSS Helmut 2016-05-26 19:13
- Doubts about NCSS zizou 2016-05-26 23:38
- doubts about NCSS Helmut 2016-05-26 19:13
- Compilation AngusMcLean 2016-05-28 00:51
- Kenward-Roger? Helmut 2016-05-28 15:59
- 90% confidence interval for R_dnm Shuanghe 2019-01-04 17:45
- 90% confidence interval for R_dnm d_labes 2019-01-05 14:01
- Visualizing lmer and limits mittyri 2019-01-06 17:00
- Visualizing lmer and limits Shuanghe 2019-01-07 11:05
- Visualizing lmer and limits d_labes 2019-01-07 15:08
- Visualizing lmer and limits mittyri 2019-01-13 23:53
- 90% confidence interval for R_dnm Shuanghe 2019-01-07 10:53
- 90% confidence interval for R_dnm d_labes 2019-01-07 15:17
- 90% confidence interval for R_dnm Shuanghe 2019-01-07 17:11
- 90% confidence interval for R_dnm d_labes 2019-01-07 18:24
- offtop: greek letters and tables mittyri 2019-01-08 00:19
- OT: greek letters and symbols Helmut 2019-02-02 16:04
- 90% confidence interval for R_dnm Shuanghe 2019-01-07 17:11
- 90% confidence interval for R_dnm d_labes 2019-01-07 15:17
- Visualizing lmer and limits mittyri 2019-01-06 17:00
- 90% confidence interval for R_dnm d_labes 2019-01-05 14:01
- REML or not d_labes 2016-05-24 16:33
- Compilation Helmut 2016-05-24 14:27
- SASian potpourri d_labes 2016-05-24 12:02
- Diagnostics: R Helmut 2016-05-23 01:22
- Diagnostics: R zizou 2016-05-22 19:07
- Diagnostics: R and Phoenix Helmut 2016-05-18 15:14
- Smith’s paper Helmut 2016-05-18 14:44
- Smith’s paper d_labes 2019-01-05 15:00
- Diagnostics ElMaestro 2016-05-18 09:20
- NCSS vs. PHX/WNL vs. SAS - Validation? mittyri 2016-05-18 08:23
- NCSS vs. PHX/WNL vs. SAS Helmut 2016-05-17 01:50
- Setup in Phoenix/WinNonlin AngusMcLean 2016-05-14 18:54
- Setup in Phoenix/WinNonlin Helmut 2016-05-14 02:26
- More information, pleaseAngusMcLean 2016-05-13 16:40
- More information, please Helmut 2016-05-12 14:34